Drug safety alert: Canagliflozin (Invokana, Invokamet) may increase the risk of leg and foot amputations

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with...

Recommended for you

  • MedWatch Drug Updates
  • 1 comment

FDA update: Type III endoleaks associated with the use of endovascular graft systems

  • MedWatch Drug Updates
  • 1 comment

FDA update: High risk of mortality and neurological adverse events when using SynCardia's TAH-t C2 Driver System

  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Blocked guidewire lumen

  • FDA Drug Updates
  • 1 comment

FDA approved Aliqopa (copanlisib) for the treatment of relapsed follicular lymphoma

  • FDA Drug Updates
  • 1 comment

FDA approved Mvasi (bevacizumab-awwb) for the treatment of cancer

  • MedWatch Drug Updates
  • 1 comment

Recall of Intralipid 20 % IV Fat Emulsion by Baxter: One lot of product exposed to subfreezing temperature

  • MedWatch Drug Updates
  • 1 comment

Case of HORV reported after intraocular Inj of a compounded triamcinolone, moxifloxacin, vancomycin

  • MedWatch Drug Updates
  • 1 comment

FDA recommends separate dosing for Kayexalate (sodium polystyrene sulfonate) from all other oral drugs

  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Intra-Aortic Balloon Pump by Datascope/MAQUET- False blood detection alarm and ingress of fluid into the pump

  • MedWatch Drug Updates
  • 1 comment

FDA alert- Not to use infant sleep positioners as it can cause suffocation

  • MedWatch Drug Updates
  • no comment

FDA statement on risks of unapproved use of Keytruda (pembrolizumab) for treatment of multiple myeloma

  • MedWatch Drug Updates
  • 1 comment

Recall of Piyanping Anti-Itch Lotion by Lucky Mart Inc.: Contain wrong active pharmaceutical ingredient

  • FDA Drug Updates
  • 1 comment

FDA approves Besponsa (inotuzumab ozogamicin) for acute lymphoblastic leukemia

  • MedWatch Drug Updates
  • 1 comment

FDA alert: Incorrect dosing of Ocaliva (obeticholic acid) associated with increased risk of serious liver injury

  • FDA Drug Updates
  • 1 comment

New targeted treatment approved for relapsed or refractory acute myeloid leukemia

  • MedWatch Drug Updates
  • 1 comment

FDA advise on use of opioid addiction medication in patients taking benzodiazipines or CNS depressants

  • MedWatch Drug Updates
  • 1 comment

Class I recall of Penumbra 3D Revascularization device by Penumbra: delivery wire may break or separate during use

  • FDA Drug Updates
  • 1 comment

FDA approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Hepatitis C

  • FDA Drug Updates
  • 1 comment

FDA approved Nerlynx (neratinib) for breast cancer

  • MedWatch Drug Updates
  • 1 comment

Recall of VV28F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical- Extension tube may separate from hub

  • MedWatch Drug Updates
  • 1 comment

Recall of Diabetes Infusion Sets by Medtronic -Vent Membrane susceptible to blocking by fluid

  • FDA Drug Updates
  • 1 comment

FDA approved Endari (L-glutamine) for sickle cell disease

  • MedWatch Drug Updates
  • 1 comment

Recall of Atar Extension Cables by Oscor- cable malfunction interrupting the pacing system

  • MedWatch Drug Updates
  • 1 comment

Recall of Novopen Echo Insulin Delivery Device by Novo Nordisk: Chemical exposure may damage cartridge holder

  • MedWatch Drug Updates
  • no comment

Recall of Baby Organic Liquid Formula by Garden of Life: Misleading direction for use

  • MedWatch Drug Updates
  • 1 comment

Recall of Activase (alteplase) 100mg by Genentech due to lack of sterility assurance

  • FDA Drug Updates
  • 1 comment

FDA approved Haegarda (C1 esterase inhibitor) for Hereditary Angioedema

  • MedWatch Drug Updates
  • 1 comment

Field Correction of system CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope

  • MedWatch Drug Updates
  • 1 comment

Recall of Clindamycin Injection USP ADD-Vantage vials by Alvogen: Presence of microbial growth

  • MedWatch Drug Updates
  • 1 comment

Recall of Oxytocin compounded with either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium